BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3143482 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08579
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REACTION ABOUT THIRTY MINUTES AFTER HAVING HER PUMP FILLED. THE PATIENT HAD BEGUN TO FEEL FAINT AND DIZZY WHILE SHE WAS BEING TRANSFERRED FROM A BED INTO HER WHEELCHAIR. IT WAS STATED THAT THE HEALTHCARE PROFESSIONAL (HCP) HAD BEEN IN THE RESERVOIR, AS SHE WAS ABLE TO PULL CLEAR LIQUID BACK. IT WAS NOTED THAT THE PATIENT HAD NOT PREVIOUSLY HAD A REACTION LIKE THAT. AT THE TIME OF REPORT, THE HCP THAT PERFORMED THE REFILL HAD TURNED THE PUMP OFF. THE DEVICE SYSTEM HAD BEEN DELIVERING BACLOFEN AND CLONIDINE. LATER THAT DAY, IT WAS REPORTED THAT THE PUMP HAD TO BE SHUT OFF DUE TO AN OVERDOSE OF THE PATIENT. THE PATIENT WAS AT THE HOSPITAL WITH A HOSPITALIST AND WAS LETHARGIC AND ON OXYGEN. IT WAS REPORTEDLY UNCLEAR IF THE EVENT WAS RELATED TO THE MEDICATION. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS BEING TURNED BACK ON. IT WAS THOUGHT THAT THERE HAD BEEN A ¿SPILL INTO THE ABDOMEN¿ WHEN THE NEEDLE WAS COMING OUT OR THE RESERVOIR HAD BEEN OVERFILLED. IT WAS STATED THAT AN MRI WAS DONE AROUND IT AND THERE WAS A ¿SMALL CENTIMETER POCKET¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243188 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O